NCT03292952

KP415 Classroom Study in Children (6-12 Years of Age) With ADHD

A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy Laboratory Classroom Study With KP415 in Children With Attention-Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Zevra Therapeutics · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed description

The study will consist of a Screening Period, an Open-Label Dose Optimization Phase, a Double-Blind Treatment Phase and a Follow-Up Visit, as follows: * Screening Period: Subjects will undergo a screening period up to 49 days prior to entering into the Open-Label Dose Optimization Phase. * Open-Label Dose Optimization Phase: During the Dose Optimization Phase, subjects will be titrated to doses of 20, 30 or 40 mg KP415 based on tolerability and best individual dose-response in the opinion of the Investigator. * Double-Blind Treatment Phase: Eligible subjects will be randomized to receive single daily doses of KP415 or Placebo for 7 days according to a randomization schedule. The dose of KP415 given in the Treatment Phase will be the same as the optimized dose of KP415 at the end of the Dose Optimization Phase. All subjects will receive their assigned treatment daily for 7 days. The dose will be the same at each day of the Treatment Period. Efficacy and safety assessments will be performed after the last dose of the Treatment Period. * Follow-Up Visit: 3 ±2 days after administration of the last dose of the Treatment Phase, subjects will enter a Follow-Up Visit to evaluate safety parameters.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	KP415 oral capsule	Daily dose
DRUG	Placebo oral capsule	Daily dose

Timeline

• Start date: 2017-12-20
• Primary completion: 2018-05-16
• Completion: 2018-05-16
• First posted: 2017-09-26
• Last updated: 2021-06-30
• Results posted: 2021-06-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study